510(k) · Cleared
ClearedEG-3630UR, Ultrasound Video Gastroscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Precision Instrument Corp. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Sep 6, 2002 as substantially equivalent to K010740 (Pentax Precision Instrument Corp., 2001) and 1 other predicate after a 137-day review. Its family tree reaches back 3 generations to 1981. 10 later devices descend from it.
- Decided
- Sep 6, 2002
- Review
- 137 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K812810 (1981). 7 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 2 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 1 generation backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- This deviceK021278 EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp. · 2002
- Descendant · cites it directly · 9 of its ownK023401 EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
- Descendant · 2 generations on · 6 of its ownK090197 EG-3870UTKPentax Medical Company · 2009 · Recalled
- Descendant · 3 generations on · 5 of its ownK130247 Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 4 of its ownK162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I.…Pentax of America, Inc. · 2017
- Descendant · 5 generations on · 3 of its ownK182004 PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc. · 2018 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003 · cites it directly9descendants
- K090197EG-3870UTKPentax Medical Company · 2009 · 2 generations on6descendants
- K130247Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · 3 generations on5descendants
- K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Pentax of America, Inc. · 2017 · 4 generations on4descendants
- K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc. · 2018 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −2 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −1 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| 0 (this device) | K021278 | EG-3630UR, Ultrasound Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| +1 | K023401 | EG-3830UT, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2003 | — |
| +2 | K090197 | EG-3870UTK | Pentax Medical Company | 2009 | 2 |
| +3 | K130247 | Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | 1 |
| +4 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope… | Pentax of America, Inc. | 2017 | — |
| +5 | K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ODG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010740 | FG-36UX, Fiber Ultrasound GastroscopeSummary page 4….1570), Endoscope and Accessories (78KOG) {876.1500} Predicated Device(s) Information: Model, Description Manufacturer PMIN# FG-36UX, Fiber Ultrasound Gastroscope PPIC K010740 EUB-6500, Ultrasound Diagnostic Scanner Hitachi America K994026 Device Description: The EG-3630UR, Ultrasound Video Gastroscope… | 2001 |
| * | K994026 | Eub-6000 Ultrasound Diagnostic ScannerSummary page 4…Device(s) Information: Model, Description Manufacturer PMIN# FG-36UX, Fiber Ultrasound Gastroscope PPIC K010740 EUB-6500, Ultrasound Diagnostic Scanner Hitachi America K994026 Device Description: The EG-3630UR, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software controlle… | 2000 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023401 | EG-3830UT, Video Ultrasound Gastroscope | 2003 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K023401 (Pentax Precision Instrument Corp., 2003) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K010740.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The EG-3630UR, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Tract. The Upper Gastrointestinal Tract includes but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, and underlying areas. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021278 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021278: EG-3630UR, Ultrasound Video Gastroscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021278
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026